The FDA on May 4, 2022, approved ENHERTU® for adult patients with unresectable or metastatic HER2-positive breast cancer, who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within 6 months of completing therapy. ENHERTU® is a product of Daiichi Sankyo, Inc.
Category: FDA Approvals
YESCARTA® (Axicabtagene ciloleucel)
The FDA on April 1, 2022, approved YESCARTA® for adult patients with Large B-Cell Lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary Central Nervous System lymphoma. YESCARTA® is a product of Kite Pharma, Inc.
PLUVICTO® (Lutetium Lu 177 vipivotide tetraxetan)
The FDA on March 23, 2022, approved PLUVICTO® for the treatment of adult patients with Prostate-Specific Membrane Antigen (PSMA)-positive metastatic Castration-Resistant Prostate Cancer (mCRPC), who have been treated with Androgen Receptor (AR) pathway inhibition and taxane-based chemotherapy. PLUVICTO® is a product of Advanced Accelerator Applications USA, Inc., a Novartis company.
KEYTRUDA® (Pembrolizumab)
The FDA on March 21, 2022, approved KEYTRUDA® (Pembrolizumab) as a single agent, for patients with advanced endometrial carcinoma that is MicroSatellite Instability-High (MSI-H) or MisMatch Repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting, and who are not candidates for curative surgery or radiation. KEYTRUDA® is a product of Merck & Co., Inc.
OPDUALAG® (Nivolumab and Relatlimab-rmbw)
The FDA on March 18, 2022, approved OPDUALAG® for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG® is a fixed-dose combination of the LAG-3-blocking antibody Relatlimab and the Programmed Death receptor-1 blocking antibody, Nivolumab. OPDUALAG® is a product of Bristol-Myers Squibb Company.
LYNPARZA® (Olaparib)
The FDA on March 11, 2022, approved LYNPARZA® for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) Human Epidermal growth factor Receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA®. LYNPARZA® is a product of AstraZeneca Pharmaceuticals, LP.
OPDIVO® (Nivolumab)
The FDA on March 4, 2022 approved OPDIVO® with platinum-doublet chemotherapy for adult patients with resectable Non-Small Cell Lung Cancer (NSCLC) in the neoadjuvant setting. OPDIVO® is a product of Bristol-Myers Squibb Company.
CARVYKTI® (Ciltacabtagene)
The FDA on February 28, 2022, approved CARVYKTI® for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a Proteasome Inhibitor (PI), an Immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. CARVYKTI® is a product of Janssen Biotech, Inc.